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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SORIN GROUP DEUTSCHLAND SORIN HEATER-COOLER SYSTEM 3T CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS

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SORIN GROUP DEUTSCHLAND SORIN HEATER-COOLER SYSTEM 3T CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bacterial Infection (1735); Endocarditis (1834); Fever (1858); Renal Failure (2041); Malaise (2359)
Event Date 10/16/2015
Event Type  Injury  
Manufacturer Narrative

The model and serial number were not provided, and the unique identifier (udi) number could not be determined. This information will be provided in a supplemental report if and when made available. The user report did not contain information regarding the reporting facility. This information will be provided in a supplemental report if and when made available. As the model number was not provided, the 510(k) number could not be determined. This information will be provided in a supplemental report if and when made available. As the serial number was not provided, the date of manufacture could not be determined. This information will be provided in a supplemental report if and when made available. Sorin group (b)(4) manufactures the sorin heater-cooler system 3t. The location where this incident occurred is unknown. This medwatch report is being filed on behalf of sorin group (b)(4). As no device information or contact information for the facility or for the initial reporter was provided in the user medwatch report, sorin group (b)(4) is unable to perform any follow-up with the customer regarding this event at this time. A review of existing complaints did not identify any event that matched the description provided in the user report. No further investigation is possible. In the event of receipt of new information, a supplemental report will be provided.

 
Event Description

On october 11, 2016, sorin group (b)(4) received a user medwatch report (mw5064988) stating that a patient was admitted to the hospital in 2015 for coronary artery bypass grafting and a valve replacement. The patient was discharged from the hospital following the procedure and presented in 2016 with complaints of 6 weeks of fevers, night sweats and malaise. The patient was diagnosed with endocarditis and renal failure requiring dialysis. Patient cultures were taken, which tested positive for non-tuberculous mycobacterium (ntm).

 
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Brand NameSORIN HEATER-COOLER SYSTEM 3T
Type of DeviceCONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
SORIN GROUP DEUTSCHLAND
lindberghstr. 25
munich, 80939
GM 80939
Manufacturer (Section G)
SORIN GROUP DEUTSCHLAND
lindberghstr. 25
munich, 80939
GM 80939
Manufacturer Contact
joan ceasar
14401 w. 65th way
arvada, CO 80004
2812287260
MDR Report Key6067009
MDR Text Key58766554
Report Number9611109-2016-00716
Device Sequence Number1
Product Code DWC
Combination Product (Y/N)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Remedial Action Other
Type of Report Initial
Report Date 10/11/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/31/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/11/2016
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 10/31/2016 Patient Sequence Number: 1
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